Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients

This study is currently recruiting participants.
Verified April 2012 by Xiamen Amoytop Biotech Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01581398
First received: February 16, 2012
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.


Condition Intervention Phase
Chronic Hepatitis C
Drug: Ypeginterferon alfa-2b
Drug: Pegasys
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Multi-center, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Combination With Ribavirin in Chinese Chronic Hepatitis C Patients

Resource links provided by NLM:


Further study details as provided by Xiamen Amoytop Biotech Co., Ltd.:

Primary Outcome Measures:
  • Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy) [ Time Frame: 24 weeks after the end of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml) [ Time Frame: at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 726
Study Start Date: April 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1(Genotype2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
Drug: Ypeginterferon alfa-2b
sc, qw, 24 weeks.
Active Comparator: A2(Genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 800mg/day
Drug: Pegasys
sc, qw, 24 weeks.
Experimental: B1(Non-genotype 2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
Drug: Ypeginterferon alfa-2b
sc, qw, 48 weeks.
Active Comparator: B2(Non-genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
Drug: Pegasys
sc, qw, 48 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18~65 years
  • Chronic HCV infection evidence: HCV RNA or anti-HCV positive>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection
  • HCV RNA≥2000IU/mL, anti-HCV positive at screening
  • Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period
  • Signed informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Mental or psychology disorder
  • ANC<1500/mm3, or PLT<90,000/mm3, or Hb<ULN(Upper limit of Normal)
  • Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment
  • Co-infection with HIV, HAV, HBV, HEV
  • Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil>2ULN, Alb<35g/L)
  • Hepatocarcinoma or suffering from any other malignant tumor
  • Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus)
  • Significant function damage in any major organs (e.g: heart, lung, kidney)
  • Involved in other investigation within the previous 3 months
  • Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g: poor compliance)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581398

Contacts
Contact: Wei Lai, MD, PhD +8610-66515490

Locations
China
Peking University People's Hospital Recruiting
Beijing, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Principal Investigator: Wei Lai, MD, PhD            
Peking University First Hospital Not yet recruiting
Beijing, China
Contact: Wang Runhua     +86592-6889121     clinical@amoytop.com    
Beijing Youyi Hospital, capital Medical University Not yet recruiting
Beijing, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
302 Military Hospital Not yet recruiting
Beijing, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Beijing Youan Hospital, Capital Medical University Not yet recruiting
Beijing, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
First Affiliated Hospital of Jilin University Not yet recruiting
Changchun, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Xiangya Hospital, Central-south University Not yet recruiting
Changsha, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Xiangya Second Hospital, Central-south University Not yet recruiting
Changsha, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
West China Hospital, Sichuan University Not yet recruiting
Chengdu, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Southwest Hospital Not yet recruiting
Chongqing, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Second Affiliated Hospital Chongqing Medical University Not yet recruiting
Chongqing, China
Contact: Wang Runhua     +86592-6889121     clinical@amoytop.com    
Fuzhou Infectious Disease Hospital Not yet recruiting
Fuzhou, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Guangzhou Eighth People's Hospital Not yet recruiting
Guangzhou, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Third Affiliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Nanfang Hospital Not yet recruiting
Guangzhou, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
First Affiliated Hospital of Guangxi Medical University Not yet recruiting
Guilin, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Affiliated Hospital of Guiyang Medical College Not yet recruiting
Guiyang, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
First Affiliated Hospital, Zhejiang University Not yet recruiting
Hangzhou, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Second Affiliated Hospital of Harbin Medical University Not yet recruiting
Harbin, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
First Affiliated Hospital of Anhui Medical University Not yet recruiting
Hefei, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Jinan Infectious Disease Hospital Not yet recruiting
Jinan, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
First Affiliated Hospital of Lanzhou University Not yet recruiting
Lanzhou, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
First Affiliated Hospital of Nanchang University Not yet recruiting
Nanchang, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Second Hospital of Nanjing Not yet recruiting
Nanjing, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Jiangsu Province Hospital Not yet recruiting
Nanjing, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
81 Military Hospital Not yet recruiting
Nanjing, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Ruijing Hospital Not yet recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Huashan Hospital Not yet recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
85 Militay Hospital Not yet recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Shanghai Public Health Clinical Center Not yet recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Renji Hospital Not yet recruiting
Shanghai, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Third Affiliated Hospital, Hebei Medical University Not yet recruiting
Shijiazhuang, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
First Affiliated Hospital, Shanxi University Not yet recruiting
Taiyuan, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Tianjin Third Central Hospital Not yet recruiting
Tianjin, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting
Wuhan, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Not yet recruiting
Wuhan, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Tangdu Hospital, Fourth Military Medical University Not yet recruiting
Xian, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Xijing Hospital Not yet recruiting
Xian, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Hennan Provincial People's Hospital Not yet recruiting
Zhengzhou, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
First Affiliated Hospital of Zhengzhou University Not yet recruiting
Zhengzhou, China
Contact: Wang Runhua, Ph.D     +86592-6889121     clinical@amoytop.com    
Sponsors and Collaborators
Xiamen Amoytop Biotech Co., Ltd.
Investigators
Principal Investigator: Wei Lai, MD, PhD Peking University People's Hospital
  More Information

No publications provided

Responsible Party: Xiamen Amoytop Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01581398     History of Changes
Other Study ID Numbers: TB1203IFN
Study First Received: February 16, 2012
Last Updated: April 18, 2012
Health Authority: China: State Food and Drug Administration

Keywords provided by Xiamen Amoytop Biotech Co., Ltd.:
Peginterferon
Pegasys
Sustained virus response
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 17, 2012